Status:
RECRUITING
A Primary Care-Based Psychosocial Intervention To Improve Cognitive & Depression Outcomes in Older Adults With MCI & Early Stage AD
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Depression
Pain
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The purpose of the study is to examine the effect of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive functioning, depression and pain-related disability in 100 older adults with cognitive...
Detailed Description
This is a Randomized Control Trial to target cognition in older adults with MCI or Early AD, depression, and chronic pain with a psychotherapeutic intervention in primary care. This project will study...
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 60 years old
- MCI or early stage probable or possible AD diagnosis (as defined by Albert et al or McKhann et al) al). Patients will have at least mild cognitive deficits defined by 16 ≤ MoCA ≤ 25.
- Montgomery Asberg Depression Rating Scale (MADRS)[55] total ≥ 5, which reflects at least some mild depressive symptoms.
- Participants will be off antidepressants, cholinesterase inhibitors or memantine or on a stable dosage for at least 12 weeks.
- Chronic pain (neuropathic, nociceptive or mixed disorders): presence of pain on most days for at least 3 months and average pain intensity score >=4.
- Clinical Dementia Rating 0.5 ≤ (CDR) ≤ 1.
- Participant will have capacity to consent.
- Participation of a study partner (e.g. caregiver/family member/significant other) is required.
Exclusion Criteria:
- Deemed to have a significant suicide risk as assessed by site PI and clinical team.
- Deemed too unstable medically or neurologically to safely enroll in a research trial.
- Deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy.
- Requiring psychiatric hospitalization at baseline for safety.
- Lack of English fluency.
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05081596
Start Date
June 3 2022
End Date
July 31 2027
Last Update
May 23 2025
Active Locations (1)
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1
Weill Cornell Medicine
White Plains, New York, United States, 10502